Lamotrigine ODT 25mg Tablets
WARNING: Severe skin reactions may happen with this drug. These include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. Sometimes, body organs may also be affected. These reactions can be deadly. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or any areas of skin; fever; chills; body aches; shortness of breath; or swollen glands. The chance of a skin reaction is raised in children between 2 and 17 years old. It may also be raised if you take valproic acid or divalproex sodium with this drug, if you start taking this drug at too high of a dose, or if your dose is raised too fast. Skin reactions have also happened without any of these. Talk with your doctor.Most cases of skin reactions have happened within 2 to 8 weeks of starting this drug, but some show up after longer treatment like 6 months. Talk with the doctor. @ COMMON USES: It is used to help control certain kinds of seizures.It is used to treat bipolar disorder.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant; Mood Stabilizer
Pharmacologic Class
Phenyltriazine derivative; Voltage-gated sodium channel blocker
Pregnancy Category
Not available
FDA Approved
Jul 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lamotrigine is a medication used to treat certain types of seizures (epilepsy) and to help prevent mood swings in people with bipolar disorder. It works by stabilizing electrical activity in the brain. The ODT (Orally Disintegrating Tablet) form dissolves quickly in your mouth.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.
Administration Instructions
To take this medication, place it on your tongue and let it dissolve. You do not need to drink water with it. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it.
Important Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually stop it to minimize the risk of side effects. If you have already stopped taking this medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food. Continue taking your medication as directed by your doctor or healthcare provider, even if you feel well.
Administration Instructions
To take this medication, place it on your tongue and let it dissolve. You do not need to drink water with it. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it.
Important Warnings
Do not change your dose or stop taking this medication without consulting your doctor, as this may cause seizures. If you need to stop taking this medication, your doctor will instruct you on how to gradually stop it to minimize the risk of side effects. If you have already stopped taking this medication, consult your doctor before restarting, as you may need to begin with a lower dose and gradually increase it.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed. Do not stop taking lamotrigine suddenly, as this can cause serious problems, including increased seizures or withdrawal symptoms. Any dose changes must be done slowly under medical supervision.
- Report any new skin rash immediately to your doctor. This is a serious side effect that requires immediate medical attention.
- Be aware that lamotrigine can cause dizziness, drowsiness, or blurred vision, especially when you first start taking it or after a dose increase. Avoid driving or operating machinery until you know how this medication affects you.
- Limit or avoid alcohol consumption, as it can increase side effects like dizziness and drowsiness.
- If you are a woman taking birth control pills, tell your doctor, as these can affect lamotrigine levels and vice versa. You may need a higher dose of lamotrigine or a different birth control method.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not take two doses at once. If you miss multiple doses, contact your doctor as you may need to restart at a lower dose and re-titrate.
Available Forms & Alternatives
Available Strengths:
- Lamotrigine 150mg Tablets
- Lamotrigine 200mg Tablets
- Lamotrigine 25mg Tablets
- Lamotrigine 100mg Tablets
- Lamotrigine 25mg Chew/disprsbl Tab
- Lamotrigine 5mg Chew/disprsbl Tab
- Lamotrigine ER 50mg Tablets
- Lamotrigine ER 200mg Tablets
- Lamotrigine ER 100mg Tablets
- Lamotrigine 300mg ER Tablets
- Lamotrigine ER 25mg Tablets
- Lamotrigine ODT 25mg Tablets
- Lamotrigine ODT 50mg Tablets
- Lamotrigine Orge Strt Kit25/100mg
- Lamotrigine Blue Starter Kit 25mg T
- Lamotrigine Green Str Kit 25/100mg
- Lamotrigine ODT 100mg Tablets
- Lamotrigine ODT 200mg Tablets
- Lamotrigine ER 250mg Tablets
- Lamotrigine ODT 25-50-100mg Tb Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized, requiring slow titration over several weeks to months to minimize rash risk. Initial doses typically 25 mg daily or every other day, increasing gradually to maintenance.
Dose Range:
100 - 500 mg
Condition-Specific Dosing:
Epilepsy (monotherapy/adjunctive):
Maintenance: 100-400 mg/day (divided once or twice daily). Dosing varies significantly based on concomitant medications (e.g., valproate, enzyme inducers).
Bipolar I Disorder (maintenance):
Maintenance: 200 mg/day (once daily). Dosing varies significantly based on concomitant medications (e.g., valproate, enzyme inducers). Max 400 mg/day for patients on enzyme inducers without valproate.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (limited data for <2 years)
Child:
Dosing established for epilepsy (adjunctive therapy) in patients âĨ2 years. Initial doses are weight-based and depend on concomitant medications, followed by slow titration. Maintenance ranges from 1-15 mg/kg/day.
Adolescent:
Dosing similar to adults for epilepsy and bipolar disorder, with careful titration based on concomitant medications.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, but caution advised.
Severe:
Use with caution. Initial dose may be reduced by 25%, and subsequent dose increases should be based on clinical response. Consider lower maintenance doses.
Dialysis:
Supplemental doses after dialysis are generally not required as only a small fraction is removed. Monitor clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
Initial, escalation, and maintenance doses should be reduced by approximately 25%.
Severe:
Initial, escalation, and maintenance doses should be reduced by approximately 50%. Monitor closely for adverse effects.
Pharmacology
Mechanism of Action
Lamotrigine is a phenyltriazine derivative that stabilizes neuronal membranes and inhibits the release of excitatory neurotransmitters (primarily glutamate and aspartate) by blocking voltage-sensitive sodium channels. It also has weak effects on voltage-gated calcium channels.
Pharmacokinetics
Absorption:
Bioavailability:
98%
Tmax:
1.4-4.8 hours (oral)
FoodEffect:
Minimal effect on absorption rate or extent.
Distribution:
Vd:
0.97-1.3 L/kg
ProteinBinding:
Approximately 55%
CnssPenetration:
Yes
Elimination:
HalfLife:
Approximately 25-33 hours (monotherapy); significantly shorter with enzyme-inducing AEDs (e.g., 13-14 hours) and significantly longer with valproate (e.g., 59-70 hours).
Clearance:
Varies significantly based on concomitant medications.
ExcretionRoute:
Urine (94%, primarily as glucuronide conjugates), feces (2%)
Unchanged:
Approximately 10% (urine)
Pharmacodynamics
OnsetOfAction:
Weeks to months (due to slow titration)
PeakEffect:
Weeks to months (after reaching maintenance dose)
DurationOfAction:
24 hours (allows for once or twice daily dosing)
Safety & Warnings
BLACK BOX WARNING
Serious skin rashes requiring hospitalization and discontinuation of treatment have been reported, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). The incidence of these rashes, which have resulted in death, is approximately 0.3% to 0.8% in pediatric patients (aged 2 to 16 years) and 0.08% to 0.3% in adults. Risk factors include concomitant valproate use, exceeding recommended initial doses, and rapid dose escalation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking (new or worsening)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Severe muscle pain or weakness
Severe joint pain or swelling
Changes in vision
Chest pain or pressure
Abnormal heartbeat (fast, slow, or irregular)
Severe dizziness or fainting
Balance problems
Uncontrolled eye movements
Flu-like symptoms
Painful periods
Changes in menstrual cycle, including spotting or bleeding between periods
Low Blood Cell Counts and Infections
This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. If you experience any of the following symptoms, contact your doctor right away:
Signs of infection, such as fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Immune System Problem: Hemophagocytic Lymphohistiocytosis (HLH)
This medication can cause a rare but life-threatening immune system problem called HLH. If you experience any of the following symptoms, contact your doctor immediately:
Fever
Swollen glands
Rash
Seizures
Confusion or decreased alertness
Balance problems
Difficulty walking (new or worsening)
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Shakiness
Trouble sleeping
Nose or throat irritation
Weight loss
Dry mouth
* Back pain
Reporting Side Effects
If you have questions about side effects or experience any symptoms that concern you, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Any new skin rash (especially if it spreads, blisters, or is accompanied by fever, swollen glands, or facial swelling)
- Fever, sore throat, or other signs of infection
- Unusual bruising or bleeding
- Yellowing of the skin or eyes (jaundice)
- Severe muscle pain or weakness
- Swelling in the face, eyes, lips, or tongue
- Difficulty breathing or swallowing
- New or worsening depression, anxiety, or suicidal thoughts/behavior
- Changes in vision (e.g., blurred vision, double vision)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you are currently taking dofetilide, as this may interact with the medication.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with certain lab tests.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may alter the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use alternative forms of birth control, such as condoms, to minimize the risk of pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. It may take several weeks to experience the full effects of the drug.
Monitoring and Lab Tests
Regular blood work is necessary, as directed by your doctor. Be sure to inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may interfere with certain lab tests.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor.
Mental Health and Suicidal Thoughts
Like other seizure medications, this drug may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal ideation. If you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes, contact your doctor immediately. If you have suicidal thoughts or actions, seek medical attention right away.
Risk of Aseptic Meningitis
This medication may increase the risk of a severe brain condition called aseptic meningitis. If you experience symptoms such as headache, fever, chills, severe nausea or vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion, contact your doctor immediately.
Medication Verification
Always verify that you have the correct medication, as some drugs may have similar names or appearances. If you notice any changes in the medication's shape, color, size, or labeling, consult with your pharmacist.
Heart-Related Warnings
If you have a history of abnormal heartbeat, heart failure, or other heart problems, discuss the risks with your doctor. Abnormal heart rhythms can increase the risk of sudden death in individuals with pre-existing heart conditions.
Pediatric Use
When administering this medication to children, use caution, as the risk of certain side effects may be higher in pediatric patients.
Interactions with Birth Control
Birth control pills and other hormone-based contraceptives may alter the levels of this medication in your body. Consult with your doctor before starting or stopping any hormone-based birth control. The risk of side effects may increase during the week when birth control pills are not active. Additionally, birth control pills and other hormone-based contraceptives may be less effective in preventing pregnancy when taking this medication. Use alternative forms of birth control, such as condoms, to minimize the risk of pregnancy.
Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.
Seizure Management
If your seizures change or worsen after starting this medication, consult with your doctor to adjust your treatment plan as needed.
Overdose Information
Overdose Symptoms:
- Dizziness
- Ataxia (loss of coordination)
- Nystagmus (involuntary eye movements)
- Decreased consciousness
- Coma
- Seizures
- Cardiac conduction abnormalities (e.g., QRS prolongation)
What to Do:
Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). Management is supportive, including gastric lavage, activated charcoal, and close monitoring of vital signs and cardiac function.
Drug Interactions
Major Interactions
- Valproate (increases lamotrigine levels significantly, requiring lower lamotrigine doses and slower titration)
- Carbamazepine, Phenytoin, Phenobarbital, Primidone, Rifampin, Lopinavir/Ritonavir, Atazanavir/Ritonavir (decrease lamotrigine levels significantly, requiring higher lamotrigine doses)
- Estrogen-containing oral contraceptives (decrease lamotrigine levels, requiring higher lamotrigine doses; lamotrigine may also reduce contraceptive efficacy)
- Dofetilide (lamotrigine may increase dofetilide levels, increasing risk of QT prolongation)
Moderate Interactions
- Risperidone (lamotrigine may decrease risperidone levels)
- Sertraline, Paroxetine (may decrease lamotrigine levels)
- Folic acid inhibitors (e.g., trimethoprim) - theoretical interaction, monitor
- Ethanol (additive CNS depression)
Monitoring
Baseline Monitoring
Baseline skin assessment
Rationale: To identify any pre-existing skin conditions and establish a baseline for monitoring serious rash.
Timing: Prior to initiation of therapy.
Renal and hepatic function tests
Rationale: To guide initial dosing and identify patients at higher risk for adverse effects due to impaired drug clearance.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential
Rationale: Although rare, blood dyscrasias can occur. Establishes baseline.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin assessment for rash
Frequency: Daily during titration, then regularly throughout therapy.
Target: Absence of new rash.
Action Threshold: Any new rash, especially if accompanied by fever, lymphadenopathy, or facial swelling, requires immediate discontinuation and medical evaluation.
Clinical monitoring for seizure control or mood stability
Frequency: Regularly, especially during titration and dose adjustments.
Target: Optimal seizure control or mood stability with minimal side effects.
Action Threshold: Worsening of seizures, mood instability, or intolerable side effects warrant dose adjustment or re-evaluation.
Monitoring for signs of hypersensitivity syndrome (DRESS)
Frequency: Regularly, especially during the first 8 weeks of therapy.
Target: Absence of fever, rash, facial swelling, lymphadenopathy, hepatic dysfunction, or eosinophilia.
Action Threshold: Any signs or symptoms require immediate discontinuation and medical evaluation.
Monitoring for suicidal ideation/behavior
Frequency: Regularly, especially at the beginning of treatment and with dose changes.
Target: Absence of new or worsening suicidal thoughts or behaviors.
Action Threshold: Report any changes in mood or behavior immediately to a healthcare provider.
Symptom Monitoring
- Skin rash (any type, especially blistering or widespread)
- Fever
- Swollen lymph nodes (lymphadenopathy)
- Facial swelling
- Sore throat
- Mouth sores
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Severe fatigue
- Worsening of depression or mood changes
- New or worsening suicidal thoughts or behavior
- Changes in seizure frequency or type
Special Patient Groups
Pregnancy
Lamotrigine crosses the placenta. While data suggest a lower risk of major congenital malformations compared to some other antiepileptic drugs, there is a potential for increased risk of oral clefts, particularly with first-trimester exposure. The decision to use lamotrigine during pregnancy should be made after careful consideration of the risks versus benefits, as uncontrolled seizures or mood episodes pose risks to both mother and fetus. Monitoring of lamotrigine levels may be considered during pregnancy due to potential changes in clearance.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts (e.g., cleft lip/palate), though overall risk of major malformations appears lower than with some other AEDs. Consider folic acid supplementation.
Second Trimester:
Clearance may increase, potentially leading to decreased lamotrigine levels and loss of seizure control. Therapeutic drug monitoring may be considered.
Third Trimester:
Clearance may continue to increase. Monitor for potential withdrawal symptoms in the neonate if maternal levels are high at delivery.
Lactation
Lamotrigine is excreted into breast milk. While generally considered compatible with breastfeeding, infants should be monitored for adverse effects such as rash, drowsiness, poor feeding, and apnea. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low to moderate risk. Monitor infant for drowsiness, poor feeding, rash, and apnea. Therapeutic drug monitoring in the infant may be considered if concerns arise.
Pediatric Use
Approved for adjunctive treatment of partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients âĨ2 years of age. Dosing is weight-based and requires careful titration, especially due to the higher incidence of serious rash in this population. Not approved for bipolar disorder in pediatric patients.
Geriatric Use
Use with caution in elderly patients, generally starting at the lower end of the dosing range and titrating slowly, due to potential for decreased renal or hepatic function and increased sensitivity to adverse effects. Monitor for dizziness and ataxia, which can increase fall risk.
Clinical Information
Clinical Pearls
- The most critical aspect of lamotrigine therapy is the slow titration schedule to minimize the risk of serious skin rashes (SJS/TEN). Patients must be educated on this and the importance of reporting any rash immediately.
- Concomitant medications significantly impact lamotrigine's pharmacokinetics. Valproate dramatically increases lamotrigine levels, while enzyme-inducing AEDs (e.g., carbamazepine, phenytoin) and estrogen-containing oral contraceptives significantly decrease them. Dosing adjustments are crucial.
- Lamotrigine ODT can be taken with or without water. It should be placed on the tongue and allowed to dissolve, then swallowed. Do not chew or crush.
- Beyond epilepsy and bipolar disorder, lamotrigine is sometimes used off-label for neuropathic pain or other mood disorders, but evidence varies.
- Patients should be advised not to abruptly discontinue lamotrigine, as this can precipitate seizures or withdrawal symptoms.
Alternative Therapies
- Other antiepileptic drugs (e.g., Levetiracetam, Carbamazepine, Valproate, Oxcarbazepine, Topiramate, Gabapentin, Phenytoin)
- Other mood stabilizers (e.g., Lithium, Valproate, Carbamazepine, Atypical antipsychotics)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for 30 tablets (generic) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the incident, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the incident, including the medication taken, the amount, and the time it occurred.